Clostridium difficile Infections (CDI): Opportunities for Prevention. Linda Savage, RN, BSN, CDONA/LTC QI Specialist, Telligen March 23, 2016

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Clostridium difficile Infections (CDI): Opportunities for Prevention Christine LaRocca, MD Medical Director, Telligen Linda Savage, RN, BSN, CDONA/LTC QI Specialist, Telligen March 23, 2016 Deanna Curry, MS, RN QI Manager, Telligen

Presentation Objectives Introduction to Telligen and current infection prevention projects with hospitals and nursing homes Review CMS quality strategy and focus on CDI Discuss the impact of CDI on patients (a CDI patient story) Focus on CDI sign and symptoms, appropriate testing and overview of prevention guidelines Review of National Healthcare Safety Network (NHSN) Healthcare-Associated Infections (HAI) resources for Long-Term Care (LTC) and the new CDI opportunity for LTC with Telligen and our state partners 2

Pop Quiz 3 In 2011, how many CDI-associated deaths occurred in the U.S.? A. 52,000 B. 29,000 C. 14,000 D. 7,000 Lessa FC, et al. Burden of Clostridium difficile Infection in the United States. N Engl J Med 2015; 372;9:825-34.

CDI by the Numbers- US Burden in 2011 453,000 CDI cases 29,300 deaths 4 83,000 (18%) first CDI recurrence Lessa FC et al. N Engl J Med 2015;372:825-834.

Who is Telligen? What is the QIN-QIO Program? Telligen: The Medicare Quality Innovation Network (QIN)-Quality Improvement Organization (QIO) for Colorado, Iowa and Illinois QIN-QIO Program Purpose: To improve the efficiency, effectiveness, economy, and quality of services delivered to Medicare beneficiaries 5

Who is Telligen? What is the QIN-QIO Program? QIN-QIOs have performance-based contracts with the Centers for Medicare & Medicaid Services (CMS) Results are measured by CMS QIN-QIOs help achieve national quality goals through focused efforts at the community level 6

CMS Quality Strategy Foundational Principles 1. Enable innovation 2. Foster learning organizations 3. Eliminate disparities 4. Strengthen infrastructure and 7 data systems Goals 1. Make care safer 2. Strengthen person and family centered care 3. Promote effective communications and care coordination 4. Promote effective prevention and treatment 5. Promote best practices for healthy living 6. Make care affordable 7

QIN- QIOs : What do we do? Champion local-level, results-oriented change Data driven, collecting and analyzing data for improvement Active engagement of patients and other partners Proactive, intentional innovation and spread of best practices Facilitate learning and action networks Creating an all teach, all learn environment Placing impetus for improvement at the bedside level e.g. hand washing Provide communities with technical assistance Consultation, education, resources, tools at no cost to support healthcare quality improvement at the community level 8

Overview of QIN-QIO Contract Tasks Improving Care Coordination and Reducing Adverse Drug Events Improving Cardiac Health and Reducing Healthcare Disparities Reducing Disparities in Diabetes Care: Everyone with Diabetes Counts (EDC) Improving Prevention Coordination through Meaningful Use of HIT and Collaborating with Regional Extension Centers Reducing Healthcare-Associated Infections (HAI) in Hospitals Reducing Healthcare-Acquired Conditions (HACs) in Nursing Homes 9

Nursing Homes and Hospitals Share Patients and Infections! 66% of NH residents who developed CDI were recently discharged from hospital Nursing home 26% of NH residents with CDI hospitalized Hospital Rochester Emerging Infection Program 10 surveillance data credit Dr. Ghinwa Dumyati for slide 35% of CDI patients discharged to NH

11

The National Landscape: Focusing on CDI Prevention is Timely The Skilled Nursing Facility Value-Based Purchasing Program 30-Day All-Cause Readmission Measure (SNFRM) (NQF #2510) and recall that CDI doubles chances of readmission Proposed Rule: Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities. Infection Control ( 483.80) Infection Prevention and Control Program Infection Prevention and Control Officer ( 483.80(b)) CMS Accountable Care Organizations (ACOs) Readmissions is a Quality Measure 12

Reducing Healthcare-Associated Infections (HAIs) in Hospitals 23 Colorado hospitals have joined HAI Reduction Collaborative Eight critical access hospitals Four rural hospitals Strong collaborations with Colorado Hospital Association, Colorado Department of Public Health & Environment, Colorado Rural Healthcare Association and Colorado Health Care Association 13

Reducing Healthcare-Associated Infections (HAIs) in Hospitals Definitions Central Line-Associated Bloodstream Infection (CLABSI) Catheter-Associated Urinary Tract Infection (CAUTI) Clostridium difficile Infection (CDI) Standard Infection Ratio (SIR) a summary measure to track HAIs 14

Reducing Healthcare-Associated Infections (HAIs) in Hospitals Goals Participating hospitals meet or exceed the current national benchmarks (SIRs) for CLABSI, CAUTI, CDI, and device utilization (Foley catheters) by October 31, 2018 15

Shirley s Story: A CDI Patient Story This short video depicts a case of a recurring CDI, leaving a patient wondering: "Will I ever fully recover? https://www.youtube.com/watch?v=jyrcaa1wa_c&list=pl8 A2OpniaYn4Gf5RL3X6NkHfdvoUzhDat&index=4 16

Clostridium difficile Infections (CDI) CDI a spore-forming, gram-positive bacterium that releases two potent toxins, toxin A and toxin B These toxins bind to certain receptors in the lining of the colon and cause diarrhea and inflammation of the large intestine One possible explanation for increase in CDI is a newer strain of CDI produces as much as 20 times more toxin A and toxin B http://www.clpct.com/professionals/testingeducation/clostridium/default.aspx 17

Clostridium difficile Infections (CDI) The incidence of Clostridium difficile infection (CDI) has risen almost 3-fold in the United States over the past decade, emphasizing the need for rapid and accurate tests for CDI. Novak-Weekley, SM 2010. Clostridium difficile Testing in the Clinical Laboratory by Use of Multiple Testing Algorithms. J. Clin. Microbiol. Journal of Clinical Microbiology, 48(3), 889-893. 18

CDI Signs and Symptoms Mild to Moderate Infection Watery diarrhea three or more times a day for two or more days Mild abdominal cramping and tenderness Severe Infection Watery diarrhea 10 to 15 times a day Abdominal cramping and pain, which may be severe Fever, Blood or pus in the stool, Nausea Dehydration, Loss of appetite, Weight loss Swollen abdomen, Kidney failure Increased white blood cell count http://www.mayoclinic.org/diseases-conditions/c-difficile/basics/symptoms/con-20029664 19

CDI Infections Asymptomatic infection - patient/resident is showing no signs or symptoms of the infection Symptomatic (active) infection patient/resident is showing signs and symptoms of the infection 20

Diagnosis of Clostridium difficile Infection Treat the Patient, Not the Test No laboratory test can diagnosis Clostridium difficile infection (CDI) CDI is a clinical diagnosis that can be supported by laboratory data. While a diagnostic assay may indicate the absence or presence of the organism or its toxins, the test by itself does not determine who does or does not have CDI Dubberke, E. R., & Burnham, C. D. (2015). Diagnosis of Clostridium difficile Infection. JAMA Internal Medicine JAMA Intern Med, 175(11), 1801. 21

CDI Clinical Laboratory Testing Methods Enzyme immunoassay (EIA). detects the presence of C. diff toxins A and B in stool. It is important to recognize that the performance of immunoassays can vary widely by product and can also be affected by protocol deviations or improper technique or specimen handling. Glutamate dehydrogenase (GDH). This assay detects the presence of the enzyme, glutamate dehydrogenase (GDH), which is produced by all C. difficile organisms. GDH is also produced by other bacteria. All positive antigen results must be combined with a toxin test to confirm the presence of C. difficile toxin. Cell cytotoxicity assay. This type of test is sensitive, but it is less widely available, more cumbersome to do and requires more than 24 to 48 hours for test results. Some facilities use both the EIA test and cell cytotoxicity assay to ensure accurate results. Polymerase chain reaction (PCR). This sensitive molecular test can rapidly detect the C. difficile toxin B gene in a stool sample and is highly accurate. Testing for CDI is unnecessary if patient is not having diarrhea or watery stools. 22

CDI Testing Methods in the Clinical Laboratory Parameters EIA Only GDH + EIA GDH + EIA + cytotoxin GDH + PCR PCR No. of Specimens 432 432 431 432 428 Sensitivity 58.3% 55.6% 83.1% 86.1% 94.4% Specificity 94.7% 98.3% 96.7% 97.8% 96.3% Accuracy 88.7% 91.2% 94.4% 95.8% 96% PPV 68.9% 87% 83.1% 88.6% 84% NPV 91.9% 91.7% 96.7% 97.2% 98.8% EIA, enzyme immunoassay; GDH, glutamate dehydrogenase; PCR, polymerase chain reaction; PPV, positive predictive value; NPV, negative predictive value Novak-Weekley, SM 2010. Clostridium difficile Testing in the Clinical Laboratory by Use of Multiple Testing Algorithms. J. Clin. Microbiol. Journal of Clinical Microbiology, 48(3), 889-893. 23

24 This material was prepared by the Lake Superior Quality Innovation Network, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The materials do not necessarily reflect CMS policy. 11SOW-MI/MN/WI-C1-15-104 101915

Guidelines for Diagnosis, Treatment and Prevention of Clostridium difficile Infections American College of Gastroenterology Only stools from patients with diarrhea should be tested for Clostridium difficile Repeat testing should be discouraged Testing for cure should not be done Routine screening for C. difficile in hospitalized patients without diarrhea is not recommended and asymptomatic carriers should not be treated Antibiotic stewardship is recommended to reduce the risk of CDI Contact precautions for a patient with CDI should be maintained at a minimum until the resolution of diarrhea See link below for full list of recommendations Am J Gastroenterol 2013; 108:478 498; doi:10.1038/ajg.2013.4; published online 26 February 2013 http://gi.org/guideline/diagnosis-and-management-of-c-difficile-associated-diarrhea-and-colitis/ 25

Guidelines for Diagnosis, Treatment and Prevention of Clostridium difficile Infections American College of Gastroenterology Patients with known or suspected CDI should be placed in a private room or in a room with another patient with documented CDI Hand hygiene and barrier precautions, including gloves and gowns, should be used by all health-care workers and visitors entering the room of any patient with known or suspected CDI Disinfection of environmental surfaces is recommended using an Environmental Protective Agency (EPA)-registered disinfectant with C. difficile-sporicidal label claim or 5000 p.p.m. chlorinecontaining cleaning agents in areas of potential contamination by C. difficile See link below for full list of recommendations Am J Gastroenterol 2013; 108:478 498; doi:10.1038/ajg.2013.4; published online 26 February 2013 http://gi.org/guideline/diagnosis-and-management-of-c-difficile-associated-diarrhea-and-colitis/ 26

CDI Prevention for Healthcare Providers Prescribe and use antibiotics carefully. Once culture results are available, check whether the prescribed antibiotics are correct and necessary Order a C. difficile test if the patient has had three or more unformed stools within 24 hours Isolate patients with C. difficile immediately Wear gloves and gowns when treating patients with C. difficile, even during short visits. Hand sanitizer does not kill C. difficile, and although hand washing works better, it still may not be sufficient alone, thus the importance of gloves Clean room surfaces thoroughly on a daily basis while treating a patient with C. difficile and upon patient discharge or transfer. Supplement cleaning as needed with use of bleach or another EPA-approved, sporekilling disinfectant When a patient transfers, notify the new facility if the patient has a C. difficile infection 27 http://www.cdc.gov/hai/organisms/cdiff/cdiff_clinicians.html

28 What s WRONG with this Picture?

What s WRONG with this Picture? Clostridium difficile is a spore-forming bacteria. These spores readily attach to clothes, hands, and equipment where they can survive for several months. People who have been on antibiotics are at greatest risk for developing a Clostridium difficile infection. Washing your hands with soap and water, cleaning equipment with bleach, and wearing isolation gowns and gloves will help to 29 stop the spread of the infection-causing spores. Additional information is available at www.cdc.gov. What s wrong: The caregiver on the left is touching the doorpost of the isolation room while wearing an isolation gown and gloves. She is wearing a mask, which is not require for contact isolation. The caregiver on the right is reaching into the isolation room without wearing an isolation gown and gloves. What s right: Do not touch any surface or item outside the patient s room while wearing your isolation gown or gloves. Put on gloves before you hand an object to someone in a contact isolation room. Hands are the number one way that Clostridium difficile spores are spread.

30 What s WRONG with this Picture?

What s WRONG with this Picture? Clostridium difficile is a spore-forming bacteria. These spores readily attach to clothes, hands, and equipment where they can survive for several months. People who have been on antibiotics are at greatest risk for developing a Clostridium difficile infection. Washing your hands with soap and water, cleaning equipment with bleach, and wearing isolation gowns and gloves will help to 31 stop the spread of the infection-causing spores. Additional information is available at www.cdc.gov. What s wrong: The transporter should not wear an isolation gown or gloves outside the patient s room. Masks are not required for contact isolation. What s right: Wash your hands and wear a gown and gloves before assisting patients while in their rooms. Patients should wash their hands before leaving their rooms. Discard your gown and gloves and wash your hands as you are leaving the room with the patient. Wash your hands and put on a fresh isolation gown and gloves prior to assisting patients at their destination.

32 What s WRONG with this Picture?

What s WRONG with this Picture? What s wrong: Used isolation gowns should not be hanging out of the container when they are removed. What s right: Contact isolation means that anyone entering the room must put on a fresh isolation gown and gloves. Before leaving, they must deposit those items into an appropriate container. Clostridium difficile is a spore-forming bacteria. These spores readily attach to clothes, hands, and equipment where they can survive for several months. People who have been on antibiotics are at greatest risk for developing a Clostridium difficile infection. Washing your hands with soap and water, cleaning equipment with bleach, and wearing isolation gowns and gloves will help to 33 stop the spread of the infection-causing spores. Additional information is available at www.cdc.gov.

National Healthcare Safety Network (NHSN) LTC Resources 34 http://www.cdc.gov/longtermcare/staff/index.html

National Healthcare Safety Network ( NHSN) LTC Resources 35 http://www.cdc.gov/nhsn/ltach/cdiff-mrsa/index.html

Top 5 Reasons for NHs to Participate in NHSN and Antibiotic Stewardship Be a leader and become part of creating the first national CDI LTC baseline. Stay ahead of future federal requirements. On July 16, 2015, CMS published a proposed rule to require facilities to have a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases. Larger hospitals are being penalized under the CMS value-based purchasing program for high infection rates. Partnering with nursing homes that have low infection rates will become an increasing priority for hospitals to thrive in their markets. The HHS National HAI Plan explicitly includes a priority focus on CDI. (http://health.gov/hcq/prevent-hai-action-plan.asp#) As Accountable Care Organizations proliferate, there will be limitations on their ability to partner with nursing homes that have less than a three-star rating. 36

New Opportunity New Opportunity - NHs can now participate in CDI NHSN data collection to establish a national baseline for LTC Learn about the principals of LTC Antibiotic Stewardship Learn effective communications through TeamSTEPPS JOIN US! 37

QUESTIONS??? Christine LaRocca @ christine.larocca@area-d.hcqis.org Deanna Curry @ deanna.curry@area-d.hcqis.org Linda Savage @ linda.savage@area-d.hcqis.org Telligen QIN-QIO Website (www.telligenqinqio.com) 38 This material was prepared by Telligen, Medicare Quality Innovation Network Quality Improvement Organization, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. 11SOW- CO-C2-1/2016-11428